1. Field of the Invention
This invention relates generally to an endoscopic implantable device and method capable of delivering, during a weight loss surgery procedure, a functional device through the patient's esophagus and to the stomach where it is attached to the stomach walls. More particularly, the present invention is referred to an endoscopic implantable device for the apposition of the stomach walls by delivering the device to the stomach, opening it up, creating a suction effect for attracting the stomach walls, closing it and leaving the device into the stomach reducing the internal volume of the stomach. Even more particularly, the present invention is referred to a method for the apposition of different types of tissue, including but not limited to, the stomach walls, fistulas, hemorrhages, etc.
2. Description of the Prior Art
Obesity is a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health, leading to reduced life expectancy. Body mass index (BMI), which compares weight and height, is used to define a person as overweight when their BMI is between 25 kg/m2 and 30 kg/m2 and obese when it is greater than 30 kg/m2.
Obesity is associated with many diseases, particularly heart disease, type 2 diabetes, breathing difficulties during sleep, certain types of cancer, and osteoarthritis. Obesity is most commonly caused by a combination of excessive dietary calories, lack of physical activity, and genetic susceptibility, though a limited number of cases are due solely to genetics, medical reasons or psychiatric illness.
Obesity is a leading preventable cause of death worldwide, with increasing prevalence in adults and children, and authorities view it as one of the most serious public health problems of the 21st century. Annual medical expenditures attributable to obesity have doubled in less than a decade, and may be as high as $147 billion per year, according to a new study by researchers at RTI International, the Agency for Healthcare Research and Quality, and the U.S. Centers for Disease Control & Prevention.
The study, published on the Health Affairs' website, reports that, between 1998 and 2006, the prevalence of obesity (body mass index greater than 30) increased by 37 percent. This increase is responsible for 89 percent of the increase in obesity costs that occurred during this time period. The results reveal that obesity is now responsible for 9.1 percent of annual medical expenditures, compared with 6.5 percent in 1998. The medical costs attributable to obesity are almost entirely a result of costs generated from treating the diseases that obesity promotes.
There have been several approached to treat obesity. The primary treatment for obesity is dieting and physical exercise. If this fails, anti-obesity drugs may be taken to reduce appetite or inhibit fat absorption. In severe cases, there are different surgery possibilities. Bariatric surgery, or weight loss surgery, is performed on the stomach and intestine of people who are dangerously obese, for the purpose of losing weight. The two most common procedures are the Roux-en-Y, which closes off a portion of the stomach and bypasses part of the intestine; and gastric banding, which places a band around the stomach. In long-term studies, the procedures caused a significant long-term loss of weight, recovery from diabetes, improvement in cardiovascular risk factors, and a reduction in mortality of 23% to 40%.
Another option is the laparoscopic bariatric surgery that requires a hospital stay of 1-2 days. Short-term complications from laparoscopic adjustable gastric banding are lower than laparoscopic Roux-en-Y surgery, and complications from laparoscopic Roux-en-Y surgery are lower than open Roux-en-Y surgery, although gastric banding and Roux-en-Y do not have the same long term effects, according to a July 2009 study of experienced centers. Overall, 30-day mortality from the surgery itself was 0.3% and the rate of major complications was 4.3%. Gastric banding had no deaths and 4.8% major complications; laparoscopic Roux-en-Y had 0.2% surgical deaths and 1.0% major complications, and open Roux-en-Y had 2.1% surgical deaths and 7.8% major complications, in 4,776 patients with an average body mass index (BMI) of 46.5. Complications were higher in patients with higher BMIs and obstructive sleep apnea.
The National Institutes of Health recommends bariatric surgery for obese people with a BMI of at least 40, and for people with BMI 35 and serious coexisting medical conditions such as diabetes.
There are several bariatric procedures known in the art. For example, US Patent Application Serial Number 2006/0047289 of the inventor of the present invention teaches about a bariatric procedure named endoscopic tissue apposition device that includes a vacuum chamber configured to securely hold a portion of tissue therein, the vacuum chamber being defined by a proximal wall and a distal wall opposite to the proximal wall. Working and vacuum channels are provided in communication with the vacuum chamber. A portion of tissue is held in the vacuum chamber when the vacuum is applied in the vacuum chamber through the vacuum channel A carrier needle is disposed on a proximal side of the vacuum chamber and is longitudinally advanceable into and across the vacuum chamber, while a punch needle is disposed on a distal side of the vacuum chamber and is configured to receive the carrier needle therein. A hold and release mechanism holds and releases the punch needle to facilitate joining portions of tissue together.
Also the USSN 2003/0208209 of Richard A. Gambale et al. discloses an improved endoscopic tissue apposition device having multiple suction ports that permits multiple folds of tissue to be captured in the suction ports with a single positioning of the device and attached together by a tissue securement mechanism such as a suture, staple or other form of tissue bonding. The improvement reduces the number of intubations required during an endoscopic procedure to suture tissue or join areas of tissue together. The suction ports may be arranged in a variety of configurations on the apposition device to best suit the desired resulting tissue orientation. The tissue apposition device may also incorporate a tissue abrasion means to activate the healing process on surfaces of tissue areas that are to be joined by the operation of the device to promote a more secure attachment by permanent tissue bonding.
U.S. Pat. No. 6,773,440 of Gannoe et al. describes a device for use in acquiring tissue folds from the anterior and posterior portions of a hollow body organ, e.g., a stomach, positioning the tissue folds for affixing within a fixation zone of the stomach, preferably to create a pouch or partition below the esophagus, and fastening the tissue folds such that a tissue bridge forms excluding the pouch from the greater stomach cavity. It also includes a transoral, endoscopic hollow organ division, including a tissue acquisition device capable of acquiring the desired tissue, a tensioning device for positioning the acquired tissue, and a fastening element to secure the outer layers of the acquired tissue such that the desired healing response is achieved.
U.S. Pat. No. 7,122,058 of Levine et al. describes an apparatus for limiting absorption of food products in specific parts of the digestive system. A gastrointestinal implant device is anchored in the stomach and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device to the stomach and a flexible sleeve to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal.
U.S. Pat. No. 7,172,613 of Wazne describes an intragastric device inserted by endoscopic path into a patient's stomach. The device includes a balloon or envelope having a specific nominal volume. The balloon is sealingly connected to connecting elements consisting of a disc forming a support base for the balloon against an inner wall of the stomach. The device also includes a flexible tube or catheter for connecting the balloon to a filling device and catching element integral with the tube or catheter. The connection elements enable a doctor to set and/or remove the balloon and to fix, either inside the patient's body, or subcutaneously the filling device and to be able to bring the balloon or envelope to its predetermined nominal volume.
United States Patent Application Serial Nr. 20070260278 of Wheeler; William K. et al. describes a an apparatus, systems, and methods for closing the base of a left atrial appendage or other tissue structure. A tissue closure device comprises a pair of legs having compliant surfaces for engaging against opposite sides of the tissue structure. A plurality of axially spaced-apart tissue-penetrating fasteners are delivered from one leg to the other to pierce the intervening tissue and hold the closure device in place on the tissue structure. This patent fails completely in describing an apparatus capable of reducing the volume of a stomach. It does not describe a clamp-like structure capable of being left into the stomach during an endoscopic procedure. This is a stapler-like device. The stapler is inserted into the patient's body. Once the spot to be treated is located, the stapler is fired and a fastener is attached to the organ. The suction device is used to open and close the device and not to attract the walls of the stomach. The device is not recoverable in the Weller patent. In the present invention, the suction is strong enough to attract the walls of the stomach. Also, the outer edges of the body have grabbing teeth that are used to keep the device in place and the volume of the stomach reduced. The Weller patent is not disclose teeth in the nature of the present invention. The Weller patent does not teach the use of any suction from the inner walls of the body so as to attract the stomach wall. As such, the Weller patent fails to show or suggest the present invention.
United States Patent Application Serial Number 20050203547 of Weller, Gary; et al. describes devices and methods for tissue acquisition and fixation, or gastroplasty These devices may be advanced in a minimally invasive manner within a patient's body, e.g., transorally, endoscopically, percutaneously, etc., to create one or several divisions within the hollow body organ. Such divisions can form restrictive barriers within a organ, or can be placed to form a pouch, or gastric lumen, smaller than the remaining stomach volume to essentially act as the active stomach such as the pouch resulting from a surgical Roux-En-Y gastric bypass procedure. Moreover, the system is configured such that once acquisition of the tissue by the gastroplasty device is accomplished, any manipulation of the acquired tissue is unnecessary as the device is able to automatically configure the acquired tissue into a desired configuration. This patent fails to describe a clamp-like device with two complementary halves, each of which including teeth for grabbing and keeping the stomach tissue together.
United States Patent Application Serial Nr. 20070213747 of Monassevitch; Leonid; et al. discloses a surgical clip assembly which includes a pair of generally linear compression elements for securing tissue between them and for applying to the secured tissue a compression force. The clip assembly has an initial, open position in which the linear compression elements may be positioned about tissue to be secured between them. The assembly also has a final, closed position where the compression elements are substantially parallel to each other, applying a compressive force to the secured tissue. The clip assembly also includes a force means disposed between the pair of compression elements and operative to transmit operational forces between them. As in the previous cases, this patent fails to describe the combination of a clamp-like device, with two complementary halves with suction means, and a set of two opposing set of teeth. This device includes two sets of teeth but they are parallel to each other. It fails to relate them to a bariatric procedure for reducing the volume of a stomach. It is not possible to reduce the volume of a stomach using this device, as it is designed for joining tissue portions at the site of organ resections
Importantly, the prior art combination would fail to show the features of the present invention as defined by independent claim 1 herein. In particular, the prior art combination fails to show the first wall and the second wall defining an “internal chamber” in the device. The prior art combination fails to show a plurality of suction nozzles that are formed on the “first wall”. The prior art combination fails to show the grabbing teeth that extend along an edge “opposite” the hinged connection between the halves of the body. Additionally, and furthermore, the prior art combination would fail to show the “grabbing teeth” that are formed along this edge such that they intermesh with each other when the body is closed.
Even though all the above mentioned methods and devices represent a partial solution, they are very invasive and sometimes the patient needs to be hospitalized for a couple of days. The risks are higher than recommended or the costs and time involved for the procedure are extremely high.
As such, an endoscopic implantable device and method for the apposition of the stomach walls for reducing the stomach internal volume is still desired in the market.